EVEROLIMUS TEVA 10 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

EVEROLIMUS

Available from:

ABIC MARKETING LTD, ISRAEL

ATC code:

L04AA18

Pharmaceutical form:

TABLETS

Composition:

EVEROLIMUS 10 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL

Therapeutic area:

EVEROLIMUS

Therapeutic indications:

• For the treatment of patients with SEGA associated with tuberous sclerosis Complex (TSC) who require therapeutic intervention but are not candidates for curative surgical resection. The effectiveness of Everolimus is based on an analysis of change in SEGA volume. Clinical benefit such as improvement in disease-related symptoms or increase in overall survival has not been demonstrated. • Treatment of progressive neuroendocrine tumors of pancreatic origin (PNET) in patients with unresectable, locally advanced or metastatic disease. The safety and effectiveness of Everolimus in the treatment of patients with carcinoid tumors have not been established.• For the treatment of hormone receptor – positive, HER2/neu negative advanced breast cancer, in combination with exemestane, in postmenopausal women without symptomatic visceral disease after recurrence or progression follwing a non – steroidal aromatase inhibitor.• Everolimus Teva is indicated for the treatment of adult patients with renal angiomyolipoma and tuberous sclerosis complex (TSC), not requiring immediate surgery. The effectiveness of Everolimus in treatment of renal angiomyolipoma is based on an analysis of durable objective responses in patients treated for a median of 8.3 months. Further follow-up of patients is required to determine long-term outcomes.• Everolimus Teva is indicated for the treatment of patients with advanced renal cell carcinoma, whose disease has progressed on or after treatment with VEGF-targeted therapy.•Treatment of unresectable, locally advanced or metastatic, well-differentiated (Grade 1 or Grade 2) non-functional neuroendocrine tumours of gastrointestinal or lung origin in adults with progressive disease

Authorization date:

2020-01-08

Patient Information leaflet

PATIENT LEAFLET IN ACCORDANCE
WITH THE PHARMACISTS’ REGULATIONS
)PREPARATIONS( – 1986
The medicine is dispensed with a doctor’s prescription only
EVEROLIMUS TEVA 2.5 MG
EVEROLIMUS TEVA 5 MG
EVEROLIMUS TEVA 7.5 MG
EVEROLIMUS TEVA 10 MG
TABLETS
COMPOSITION:
Each tablet of Everolimus Teva 2.5 mg contains:
Everolimus 2.5 mg
Each tablet of Everolimus Teva 5 mg contains:
Everolimus 5 mg
Each tablet of Everolimus Teva 7.5 mg contains:
Everolimus 7.5 mg
Each tablet of Everolimus Teva 10 mg contains:
Everolimus 10 mg
FOR INFORMATION ABOUT INACTIVE INGREDIENTS AND
ALLERGENS IN THE PREPARATION see section 2 - “Important
information about some ingredients of the medicine”
and section 6 - “Additional information”.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING
the
m e d i c i n e .
T h i s
l e a f l e t
c o n t a i n s
c o n c i s e
i n f o r m a t i o n
a b o u t
t h e
m e d i c i n e .
I f
y o u
h a v e
a d d i t i o n a l
q u e s t i o n s ,
r e f e r
t o
t h e
d o c t o r
o r
t h e
pharmacist.
T h i s
m e d i c i n e
h a s
b e e n
p r e s c r i b e d
f o r
t r e a t m e n t
o f
y o u r
i l l n e s s .
D o
n o t
p a s s
i t
o n
t o
o t h e r s .
I t
m a y
h a r m
t h e m
e v e n
i f
i t
s e e m s
t o
y o u
t h a t
t h e i r
i l l n e s s
i s
similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
Everolimus Teva is intended for:
Treatment of patients with a brain tumor of the
Subependymal Giant Cell Astrocytoma )SEGA(
type associated with Tuberous Sclerosis Complex
)TSC( for whom surgery is not appropriate.
Treatment of adult patients with a kidney tumor
known as Angiomyolipoma )AML( when the kidney
tumor does not require immediate surgery. This
type of tumor is connected with a genetic condition
known as Tuberous Sclerosis Complex.
Treatment
of
patients
with
advanced
neuroendocrine tumors of pancreatic origin that
cannot be surgically removed, that have advanced
locally or metastatic disease.
Treatment of hormone receptor-positive and
HER2-negative advanced breast cancer, in
conjunction with exemestane, in postmenopa